Director, Regulatory Affairs and Quality Assurance 899 West … · 2017-09-01 · 513(f)(2) of the...

23andMe, Inc.

Lisa Charter

Director, Regulatory Affairs and Quality Assurance

899 West Evelyn Ave

Mountain View, CA 94041

Re: DEN170046

Trade/Device Name: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected

Variants)

Regulation Number: 21 CFR 21 CFR 866.6090

Regulation Name: Cancer Predisposition Risk Assessment System

Regulatory Class: Class II

Product Code: QAZ

Dated: September 1, 2017

Received: September 5, 2017

Dear Ms. Charter:

This letter corrects our letter dated March 6, 2018.

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has

completed its review of your De Novo request for classification of the 23andMe PGS Genetic Health Risk

Report for BRCA1/BRCA2 (Selected Variants) with the following indications for use:

The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically

relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years

with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health

risks, including the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected

Variants). The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is

indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT

variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast

and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at

increased risk of developing prostate cancer. The three variants included in this report are most

common in people of Ashkenazi Jewish descent and do not represent the majority of BRCA1/BRCA2

variants in the general population. The test report does not describe a person’s overall risk of

developing any type of cancer, and the absence of a variant tested does not rule out the presence of

other variants that may be cancer-related. This test is not a substitute for visits to a healthcare

provider for recommended screenings or appropriate follow-up and should not be used to determine

any treatments.

January 17, 2019

– Ms. Lisa Charter DEN170046

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), and substantially

equivalent devices of this generic type, into Class II under the generic name “Cancer Predisposition Risk

Assessment System.”

FDA identifies this generic type of device as: Cancer Predisposition Risk Assessment System.

A Cancer Predisposition Risk Assessment System is a qualitative in vitro molecular diagnostic

system used for determining predisposition for cancer where the result of the test may lead to

prophylactic screening, confirmatory procedures, or treatments that may incur morbidity or mortality

to the patient. The test could help to inform conversations with a healthcare professional. This

assessment system is for over-the-counter use. This device does not determine the person’s overall

risk of developing any types of cancer. This test is not a substitute for visits to a healthcare provider

for recommended screenings or appropriate follow-up and should not be used to determine any

treatments.

Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the

Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This new law

provides two options for De Novo classification. First, any person who receives a "not substantially

equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified

under the Act may, within 30 days of receiving notice of the NSE determination, request FDA to make a

risk-based classification of the device under section 513(a)(1) of the Act. Alternatively, any person who

determines that there is no legally marketed device upon which to base a determination of substantial

equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the

Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the

device. This classification shall be the initial classification of the device. Within 30 days after the issuance

of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device

type.

On September 5, 2017, FDA received your De Novo requesting classification of the 23andMe PGS Genetic

Health Risk Report for BRCA1/BRCA2 (Selected Variants). The request was submitted under section

513(f)(2) of the FD&C Act. In order to classify the 23andMe PGS Genetic Health Risk Report for

BRCA1/BRCA2 (Selected Variants) into class I or II, it is necessary that the proposed class have sufficient

regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its

intended use.

After review of the information submitted in the De Novo request FDA has determined that, for the

previously stated indications for use, the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2

(Selected Variants) can be classified in class II with the establishment of special controls for class II. FDA

believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the

device type. The identified risks and mitigation measures associated with the device type are summarized in

the following table:


Table 1 – Identified Risks to Health and Identified Mitigations

Identified Risks to Health Identified Mitigations

Incorrect understanding of the device and test

system General controls and special controls (1), (3) and (4)

Incorrect test results (false positives, false

negatives)

General controls and special controls (1), (2), (3) and

(4)

Incorrect interpretation of test results General controls and special controls (1), (3) and (4)

In combination with the general controls of the FD&C Act, a Cancer Predisposition Risk Assessment System

is subject to the following special controls:

(1) The 21 CFR 809.10 compliant labeling and any pre-purchase page and test report generated, unless

otherwise specified, must include:

(i) An intended use that specifies in the indications for use the genetic variants detected by the

test. The specific variants must be appropriately validated as described in paragraphs

(b)(4)(xii) and (b)(4)(xiii) of this section.

(ii) A section addressed to users with the following information:

(A) A warning statement accurately disclosing the genetic coverage of the test in lay terms,

including information on variants not queried by the test, and the proportion of pathogenic

variants in the genes that the assay detects in a specific population as identified in

paragraph (b)(1)(i) of this section. The warning statement must indicate that the test [does

not/ may not, as appropriate] detect all genetic variants related to the genetic disease, and

that the absence of a variant tested does not rule out the presence of other genetic variants

that may impact cancer risk. The warning statement must also include the relevant

population for which the variants reported by the test are most relevant.

(B) The limiting statement explaining that some people may feel anxious about getting genetic

test health results. This is normal. If the potential user feels very anxious, such user should

speak to his or her doctor or other healthcare professional prior to collection of a sample

for testing. This test is not a substitute for visits to a doctor or other healthcare

professional. Users should consult with their doctor or other healthcare professional if

they have any questions or concerns about the results of their test or their current state of

health.

(C) The limiting statement that a user’s ethnicity may affect whether the test is relevant for

them and may also affect how their genetic health results are interpreted.

(D) A warning statement that the test is not a substitute for visits to a healthcare professional

for recommended screenings, and should not be used to determine any treatments or

medical interventions.


(E) A warning statement that the test does not diagnose cancer or any other health conditions

and should not be used to make medical decisions. The warning statement must indicate

that the results should be confirmed in a clinical setting before taking any medical action.

(F) The limiting statement explaining that other companies offering a genetic risk test may be

detecting different genetic variants for the same disease, so the user may get different

results using a test from a different company.

(G) If applicable, a limiting statement that states the test does not test for variants in other

genes linked to hereditary cancer.

(H) The limiting statement explaining that this test does not account for non-genetic factors

and that other factors such as environmental and lifestyle risk factors may affect the risk

of developing a given disease.

(I) Information to potential purchaser or actual test report recipient about how to obtain

access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and

post-test counseling.

(J) The limiting statement explaining that this test is not intended to tell you anything about

your current state of health, or be used to make medical decisions, including whether or

not you should take a medication or how much of a medication you should take.

(K) The limiting statement explaining that the laboratory may not be able to process a sample,

and a description of the next steps to be taken by the manufacturer and/or the customer, as

applicable.

(iii)A section in your 21 CFR 809.10 labeling and any test report generated that is for healthcare

professionals who may receive the test results from their patients with the following

information:

(A) The limiting statement explaining that this test is not intended to diagnose a disease,

determine medical treatment or other medical intervention, or tell the user anything

about their current state of health.

(B) The limiting statement explaining that this test is intended to provide users with their

genetic information to inform health-related lifestyle decisions and conversations with

their doctor or other healthcare professional.

(C) The limiting statement explaining that any diagnostic or treatment decisions should be

based on confirmatory prescription testing and/or other information that is determined

to be appropriate for the patient (e.g., additional clinical testing and other risk factors

that may affect individual risk and health care).

(2) The genetic test must use a sample collection device that is FDA-cleared, -approved, or -classified as

510(k) exempt, with an indication for in vitro diagnostic use in over-the-counter DNA testing.


(3) The device’s labeling must include a hyperlink to the manufacturer’s public website where the

manufacturer shall make the information identified in paragraph (b)(3) of this section publicly

available. The manufacturer’s home page, as well as the primary part of the manufacturer’s website

that discusses the device, must provide a hyperlink to the Web page containing this information and

must allow unrestricted viewing access. If the device can be purchased from the Web site or testing

using the device can be ordered from the Web site, the same information must be found on the Web

page for ordering the device or provided in a publicly accessible hyperlink on the Web page for

ordering the device. Any changes to the device that could significantly affect safety or effectiveness

would require new data or information in support of such changes, which would also have to be

posted on the manufacturer’s website. The information must include:

(i) An index of the material being provided to meet the requirements in paragraph (b)(3) of this

section and its location.

(ii) Technical information about the device, as specified in paragraph (b)(4) of this section.

(iii)A section that highlights summary information that allows the user to understand how the test

works and how to interpret the results of the test. This section must, at a minimum, be written

in plain language understandable to a lay user and include:

(A) Consistent explanations of the risk of disease associated with all variants included in

the test, variants not included in the test, and specific considerations by ethnicity. If

there are different categories of risk, the manufacturer must provide literature

references and/or data that support the different risk categories. If there will be

multiple test reports and multiple variants, the risk categories must be defined

similarly among them. For example, “increased risk” must be defined similarly

between different test reports and different variant combinations.

(B) Clear context for the user to understand the context in which the cited clinical

performance data support the risk reported. This includes, but is not limited to, any

risks that are influenced by ethnicity, age, gender, environment, and lifestyle choices.

(C) Materials that explain the main concepts and terminology used in the test that include:

(1) Definitions: scientific terms that are used in the test reports.

(2) Pre-purchase page: this page must contain information that informs the user

about what information the test will provide. This includes, but is not limited

to, variant information, the condition(s) or disease(s) associated with the

variant(s), professional guideline recommendations for general genetic risk

testing, the limitations associated with the test (e.g., test does not detect all

variants related to the disease), relevance of race/ethnicity, and any

precautionary information about the test the user should be aware of before

purchase. When the test reports the risk of a life-threatening or irreversibly

debilitating disease or condition for which there are few or no options to

prevent, treat, or cure the disease, a user opt-in page must be provided. This


opt-in page must be provided for each disease type that falls into this category

and must provide specific information relevant to each test result. The opt-in

page must include:

(i) An option to accept or decline to receive this specific test result;

(ii) Specification of the risk involved if the user is found to have the

specific genetic test result;

(iii)Summary of professional guidelines that recommend when genetic

testing for the associated target condition is or is not recommended;

(iv) A recommendation to speak with a healthcare professional, genetic

counselor, or equivalent professional before getting the results of the

test;

(v) The implications of receiving a no variants detected result; and

(vi) The statement that the test does not diagnose cancer or any other health

conditions and should not be used to make medical decision. Results

should be confirmed in a clinical setting before taking any medical

action. Users should consult with a healthcare professional before

taking any medical action.

(3) Frequently asked questions (FAQ) page: This page must provide information

that is specific for each variant/disease pair that is reported. Information

provided in this section must be scientifically valid and supported by

corresponding peer-reviewed publications. The FAQ page must explain the

health condition/disease being tested, the purpose of the test, the information

the test will and will not provide, the relevance of race and ethnicity to the test

results, information about the population to which the variants in the test is

most applicable, the meaning of the result(s), other risk factors that contribute

to disease, appropriate follow-up procedures, how the results of the test may

affect the user’s family, including children, and links to resources that provide

additional information.

(4) The device labeling must include a technical information section containing the following

information:

(i) Gene(s) and variant(s) the test detects using standardized nomenclature, Human Genome

Organization (HUGO) nomenclature and coordinates as well as Single Nucleotide

Polymorphism Database (dbSNP) reference SNP numbers (rs#).

(ii) A statement indicating that more than 1,000 variants in the BRCA1 and BRCA2 genes are

known to increase cancer risk, as applicable.


(iii)Scientifically established disease-risk association of each variant detected and reported by

the test. This risk association information must include:

(A) Genotype-phenotype information for the reported variants.

(B) When available, a table of expected frequency in the general population and

different ethnicities, and risks of developing the disease in relevant ethnic

populations and the general population.

(C) Information such as peer reviewed published literature and/or professional

guidelines used to determine what types and levels of evidence will distinguish

whether the selected variants are reported as “are associated with increased risk”

versus “may be associated with increased risk” of developing other cancers. All

selected variants must be appropriately validated as required under paragraph

(b)(1)(i) of this section. For selected variants reported as “are associated with

increased risk”, the clinical evidence must be demonstrated with sufficient

information (e.g., professional guidelines and consistent associations in peer-

reviewed published literature). For the selected variants reported as “may be

associated with increased risk”, the clinical evidence must be reported in

professional guidelines but peer-reviewed published literature may not be

consistent.

(D) A statement about the current professional guidelines for testing these specific

gene(s) and variant(s) for the specified disease(s).

(1) If professional guidelines are available, provide the recommendations in

the professional guideline(s) for the gene, variant, and disease, for when

genetic testing should or should not be performed, and cautionary

information that should be communicated when a particular gene and

variant is detected.

(2) If professional guidelines are not available, provide a statement that the

professional guidelines are not available for these specific gene(s) and

variant(s).

(iv) The specimen type (e.g., saliva, whole blood).

(v) Assay steps and technology used.

(vi) Specification of required ancillary reagents, instrumentation, and equipment.

(vii) Specification of the specimen collection, processing, storage, and preparation methods.

(viii) Specification of risk mitigation elements and description of all additional procedures,

methods, and practices incorporated into the directions for use that mitigate risks associated

with testing.


(ix) Information pertaining to the probability of test failure (e.g., percentage of tests that failed

quality control) based on data from clinical samples, a description of scenarios in which a test

can fail (i.e., low sample volume, low DNA concentration, etc.), how users will be notified of

a test failure, and the nature of follow-up actions on a failed test to be taken by the user and

the manufacturer.

(x) When available, information specifying the probability of a false negative and false positive

analytical result and any additional considerations by ethnicity.

(xi) Specification of the criteria for test result interpretation and reporting, including any

distinctions between risk categories (i.e., increased risk and greatly increased risk; are

associated and may be associated).

(xii) Information that demonstrates the performance characteristics of the test including:

(A) Accuracy of study results for each claimed specimen type.

(1) Accuracy of the test shall be evaluated with fresh clinical specimens

collected and processed in a manner consistent with the test’s

instructions for use. If this is impractical, fresh clinical samples may be

substituted or supplemented with archived clinical samples. Archived

samples shall have been collected previously in accordance with the

instructions for use, stored appropriately, and randomly selected. In

some limited circumstances, use of contrived samples or human cell

line samples may also be appropriate and used as an acceptable

alternative. The contrived or human cell line samples shall mimic

clinical specimens as much as is feasible and provide an unbiased

evaluation of the test’s accuracy.

(2) Accuracy must be evaluated by comparison to bidirectional Sanger

sequencing or other methods identified as appropriate by FDA.

Performance criteria for both the comparator method and the test must

be pre-defined and appropriate to the test’s intended use. Detailed study

protocols must be provided.

(3) Information provided shall include the number and type of specimens,

broken down by clinically relevant variants for each indicated report

that were compared to bidirectional sequencing or other methods

identified as appropriate by FDA. The accuracy as positive percent

agreement (PPA) and negative percent agreement (NPA), must be

measured, and accuracy point estimates must be >99% (both per

reported variant and overall). Uncertainty of the point estimate must be

within an acceptable range, as identified by FDA, and must be

presented using the 95% confidence interval.


(4) Sufficient specimens must be tested per genotype and must include all

genotypes that will be included in the tests and reports. The number of

samples tested in the accuracy study for each variant reported must be

based on the variant frequency.

(5) Any no calls (i.e., absence of a result) or invalid calls (e.g., failed

quality control) in the study must be included in accuracy study results

and reported separately. The percent of final ‘no calls’ or ‘invalid calls’

must be clinically acceptable. Variants that have a point estimate for

PPA or NPA of <99% (incorrect test results compared to bidirectional

sequencing or other methods identified as appropriate by FDA) must

not be incorporated into test claims and reports. Accuracy measures

generated from clinical specimens versus contrived samples or cell

lines must be presented separately. Results must be summarized and

presented in tabular format, by sample and by genotype.

(6) Point estimate of PPA for each genotype must be calculated as the

number of correct calls for that genotype divided by the number of

samples known to contain that genotype. The point estimate of NPA for

each genotype should be calculated as the number of correct calls that

do not contain that genotype divided by the number of samples known

to not contain that genotype. ‘No calls’ should not be included in these

calculations. Point estimates should be calculated along with 95% two-

sided confidence intervals.

(B) Precision and reproducibility data must be provided using multiple instruments

and multiple operators, on multiple non-consecutive days, and using multiple

reagent lots. The sample panel must include specimens from the claimed

sample type (e.g., saliva) representing all genotypes for each variant (e.g., wild

type, heterozygous, and homozygous). Performance criteria must be

predefined. A detailed study protocol must be created in advance of the study

and then followed. The failed quality control (FQC) rate must be indicated

(i.e., the total number of sample replicates for which a sequence variant cannot

be called (no calls) or that fail sequencing quality control (QC) criteria divided

by the total number of replicates tested). It must be clearly documented

whether results were generated from clinical specimens, contrived samples, or

cell lines. The study results shall state, in a tabular format, the variants tested in

the study and the number of replicates for each variant, and what conditions

were tested (i.e., number of runs, days, instruments, reagent lots, operators,

specimens/type, etc.). The study must include all extraction steps from the

claimed specimen type or matrix, unless a separate extraction study for the

claimed sample type is performed. If the device is to be used at more than one

laboratory, different laboratories must be included in the precision study (and

reproducibility across sites must be evaluated). Any no calls or invalid calls in

the study must be listed as a part of the precision and reproducibility study

results.


(C) Analytical specificity data: data must be provided evaluating the test

performance (e.g., specimen extraction and variant detection) effect of

potential endogenous and exogenous interferents relevant to the specimen type,

and assessment of cross-contamination. Alternatively, for each suspected

interfering mutation for which data is not provided demonstrating the effect of

the interfering variant, the manufacturer must clearly identify the suspected

interfering variants in the labeling, including but not limited to user test

reports, and indicate that the impact the interfering variants may have on the

test’s performance has not been studied by providing a statement that reads, “It

is possible that the presence of [insert identifying information for the suspected

interfering variant] in a sample may interfere with the performance of this test.

However, its effect on the performance of this test has not been studied.”

(D) Analytical sensitivity data: data must be provided demonstrating the minimum

amount of DNA that will enable the test to perform correctly in 95% of runs.

(E) Device stability data: the manufacturer must establish upper and lower limits

of input nucleic acid, sample, and reagent stability that will achieve the test’s

claimed accuracy and reproducibility. The manufacturer must evaluate stability

using wild-type, heterozygous, and homozygous samples. Data supporting

such claims must be provided.

(F) Specimen Type and matrix comparison data: specimen type and matrix

comparison data must be generated if more than one specimen type can be

tested with this device, including failure rates for the different specimens.

(xiii) Clinical Performance Summary

(A) Information to support the clinical performance of each variant in the specific

condition which is labeled as “are associated with increased risk” and reported

by the test must be provided, as identified in paragraph (b)(4)(iii)(C) of this

section.

(B) Manufacturers must organize information by the specific variant combination

as appropriate (e.g., wild type, heterozygous, homozygous, compound

heterozygous, hemizygous genotypes). For each variant combination,

information must be provided in the clinical performance section to support

clinical performance for the risk category (e.g., not at risk, increased risk). For

each variant combination, a summary of key results must be provided in

tabular format or using another method identified as appropriate by FDA to

include the appropriate information regarding variant type, data source,

definition of the target condition (e.g., disease), clinical criteria for determining

whether the target disease is present or absent, description of subjects with the

target disease present and target disease absent (exclusion or inclusion criteria),

and technical method for genotyping. When available, information on the


effect of the variant on risk must be provided as the risk of a disease (lifetime

risk or lifetime incidences) for an individual compared with the general

population risk.

(xiv) User comprehension study: information on a study that assesses comprehension of the

test process and results by potential users of the test, must be provided, including the

following, as appropriate:

(A) The test manufacturer must provide a genetic health risk education module to

naïve user comprehension study participants prior to their participation in the

user comprehension study. The module must define terms that are used in the

test reports and explain the significance of genetic risk reports.

(B) The test manufacturer must perform pre- and post-test user comprehension

studies. The comprehension test questions must directly evaluate the material

being presented to the user as described in paragraph (b)(3)(ii).

(C) The manufacturer must provide a justification from a physician and/or genetic

counselor that identifies the appropriate general and variant-specific concepts

contained within the material being tested in the user comprehension study to

ensure that all relevant concepts are incorporated in the study.

(D) The user study must meet the following criteria:

(1) The study participants must comprise a statistically sufficient sample

size and demographically diverse population (determined using

methods such as quota-based sampling) that is representative of the

intended user population. Furthermore, the study participants must

comprise a diverse range of age and educational levels and have no

prior experience with the test or its manufacturer. These factors shall be

well-defined in the inclusion and exclusion criteria.

(2) All sources of bias (e.g., non-responders) must be predefined and

accounted for in the study results with regard to both responders and

non-responders.

(3) The testing must follow a format where users have limited time to

complete the studies (such as an on-site survey format and a one-time

visit with a cap on the maximum amount of time that a participant has

to complete the tests).

(4) Users must be randomly assigned to study arms.

Test reports in the user comprehension study given to users must define

the target condition being tested and related symptoms, explain the

intended use and limitations, including warnings, for the test, explain

the relevant ethnicities in regard to the variant tested, explain genetic


health risks and relevance to the user’s ethnicity, and assess

participants’ ability to understand the following comprehension

concepts: the test’s limitations, purpose, appropriate action, test results

and other factors that may have an impact on the test results.

(5) Study participants must be untrained, be naïve to the test subject of the

study, and be provided the labeling prior to the start of the user

comprehension study.

(6) The user comprehension study must meet the predefined primary

endpoint criteria, including a minimum of a 90 percent or greater

overall comprehension rate (i.e., selection of the correct answer) for

each comprehension concept. Other acceptance criteria may be

acceptable depending on the concept being tested. Meeting or

exceeding this overall comprehension rate demonstrates that the

materials presented to the user are adequate for over-the-counter use.

(7) The analysis of the user comprehension results must include:

(i) Results regarding reports that are provided for each

gene/variant/ethnicity tested;

(ii) Statistical methods used to analyze all data sets; and

(iii) Completion rate, non-responder rate, and reasons for

nonresponse/data exclusion. A summary table of

comprehension rates regarding comprehension concepts (e.g.,

purpose of test, test results, test limitations, ethnicity relevance

for the test results, appropriate actions following receipt of

results, etc.) for each study report must be included.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket

notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket

notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device

type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety

and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification

requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a

premarket notification containing information on the Cancer Predisposition Risk Assessment System they

intend to market prior to marketing the device.

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a

determination that your device complies with other requirements of the FD&C Act or any Federal statutes

and regulations administered by other Federal agencies. You must comply with all the FD&C Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR

Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR

803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR


Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the

FD&C Act); 21 CFR 1000-1050.

A notice announcing this classification order will be published in the Federal Register. A copy of this order

and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection

between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market your device as described in the De Novo request,

subject to the general control provisions of the FD&C Act and the special controls identified in this order.

For comprehensive regulatory information about medical devices and radiation-emitting products, please see

Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone

(1-800-638-2041 or 301-796-7100).

If you have any questions concerning the contents of the letter, please contact Soma Ghosh, Ph.D. at 240-

402-5333.

Sincerely,

Reena Philip, Ph.D.

Director

Division of Molecular Genetics and Pathology

Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

http://www.fda.gov/Training/CDRHLearn

http://www.fda.gov/DICE

mailto:%[email protected]

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